Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals (I-CRECT)

Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals

Carbapenem resistant Enterobacteriaceae (CRE) colonization of patients discharged from hospitals is a source of transmission to the community. In a cluster randomized controlled trial the effect of a bundle of interventions will be assessed on CRE transmission from CRE+ index patient discharged from hospital to HouseHold (HH) members. The districts in two provinces will be randomized to intervention or control. An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic (AB) use. The effect will be evaluated on CRE transmission between HH members, livestock and environment through consecutive CRE screening using fecal and hospital effluent samples cultured on carbapenem selective media. Knowledge, Attitudes, Practice surveys with smartphones will assess health seeking, AB use and hygiene adherence, hence detecting the effect of interventions. If transmission of CRE +/- Colistin Resistant Enterobacteriaceae (CoRE, common among livestocks) is detected the source will be investigated including livestock and food, targeted information will be given and evaluated. In hospitals the effect of cohort care will be assessed on CRE acquisition, hospital acquired infection, treatment outcome, costeffectiveness and contamination in sewage water. Mechanisms of resistance, relatedness of CRE isolates in different One Health departments, and rate of CRE transmission from humans to animals and vice versa, will be assessed through Whole Genome Sequencing (WGS).

Study Overview

• Status: Recruiting
• Conditions: Antibiotic Resistant Infection; Carbapenem-Resistant Enterobacteriaceae Infection
• Intervention / Treatment: Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention; Behavioral: Hospital Cohort Care Intervention at the hospital

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phuc Pham-Duc, MD, PhD; Phone Number: +84 904049969; Email: pdp@huph.edu.vn
• Study Contact Backup: Name: Viet-Linh Nguyen, BVetMed, PhD; Email: vietlinh1603@gmail.com

Study Locations

• Vietnam
  • Thai Binh
    • Thái Bình, Thai Binh, Vietnam, 06122
      • Recruiting
      • Thai Binh Pediatric Hospital
      • Contact: Thi Nhu Pham, MD; Phone Number: 0986155211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients under 2 years old at the selected hospital are highly appreciated to join the study.

Exclusion Criteria:

• Patients not from the selected hospital and individuals outside the selected province

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention district; An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.	Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention; The intervention will focus on two main measurable outcomes: 1) Decrease feco-oral-animal transmission route to prevent in-HH and community spread of CRE +/- CoRE. 2) Decrease unindicated community use of ABs for humans and animals. This WP focuses on a one health intervention in collaboration with local health authorities, developing and implementing an HH Education Communication Hygiene Intervention (HECHI) to improve HH hygiene and health management and reduce the risk of transmission between humans and animals, a Provider Engagement Intervention (PEI) to improve case management of common infection and decrease unindicated AB, and and a Livestock AB Intervention (LAI) to reduce the use of AB in livestock through improved biosecurity conditions and animal husbandry.
Active Comparator: cohort care at the hospital; A laminated note (yellow for "suspicious CRE carrier": green for (CRE-) patients and red for (CRE+) patients) should be put on the front of the patients' bed.	Behavioral: Hospital Cohort Care Intervention at the hospital; There will be 3 different cohort groups for the patients: 1) Unknown CRE colonisation status with increased barrier precautions (all patients until screening results arrive will belong to this group unless there are available screening results from referral hospital), 2) CREpos, and 3) CREneg. CREpos patients (2) will be treated in one area of the ICUs by specially assigned nurses/personnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community	The presence of CRE in hospital wastewater before and after treatment will be compared to evaluate the effectiveness of the treatment system on preventing the spreading of AMR to the community.	24 months from the starting of the project
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater	The CRE isolated from rectal swab of patient admitted to hospital, household members, animals and wastewater will be subjected to Whole Genome Sequencing using Oxford MinION Nanopore/Illumina Miseq sequencing and bioinformatics analysis to investigate the mechanisms of resistance in different One-Health compartments.	24 months from the starting of the project
Change the prevalence of CRE colonisation	The intervention at hospital will lead to the reduction of CRE colonisation, hospital acquire infection, treatment duration and costs.	12 months from the starting of recruitment patients
Cheng th prevalence of CRE transmission in the household	The Household Education Communication Hygiene Intervention expected to reduce the transmission of CRE from index patient to household member.	12 months from the starting of recruitment community participants
Change the awareness regarding AMR of local people	The understanding on AMR, particularly of CRE, proper use of antibiotic for both humans and animals, will be improved. This will be measured through the quantitative questionnaires.	18 months from the starting of recruitment community participants

Collaborators and Investigators

• Sponsor: Hanoi University of Public Health
• Collaborators: Karolinska Institutet; University of Copenhagen; National Children's Hospital, Vietnam; Universität Tübingen; Linkoping University; Centre de coopération internationale en recherche agronomique pour le développement (CIRAD); International Centre for Antimicrobial Resistance Solutions
• Investigators: Principal Investigator: Mattias Larsson, MD, Karolinska Institutet; Principal Investigator: Thirumalaisamy Velavan, PhD, University of Tübingen, Germany; Study Director: Håkan Hanberger, Linköping University, Sweden; Principal Investigator: Flavie Goutard, PhD, CIRAD, France; Principal Investigator: Yaovi Mahuton Gildas Hounmanou, PhD, University of Copenhagen; Principal Investigator: Minh-Dien Tran, Vietnam National Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Enterobacteriaceae Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: JPIAMR 2021-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No